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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213977
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONSURA ETHINYL ESTRADIOL; NORELGESTROMIN 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/25/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2022 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

ONSURA

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.035MG/24HR;0.15MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ETHINYL ESTRADIOL AND NORELGESTROMIN ETHINYL ESTRADIOL; NORELGESTROMIN 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 213950 AMNEAL
ONSURA ETHINYL ESTRADIOL; NORELGESTROMIN 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 213977 TEVA PHARMS USA
XULANE ETHINYL ESTRADIOL; NORELGESTROMIN 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 200910 MYLAN TECHNOLOGIES
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